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PreQMS
AI-powered FDA 510(k) documentation and traceability
Hi Product Hunt! 👋 I'm Tolga, the founder of PreQMS.
Over the years, I've seen how much time medical device teams spend creating and maintaining documentation for FDA 510(k) submissions. Requirements, traceability, risk management, verification, and technical documentation are often spread across multiple tools and updated manually, making the process slow and difficult to maintain.
That's why I built **PreQMS**.
PreQMS is an AI-powered platform designed specifically for medical device companies to help them:
* Generate requirements and regulatory documentation with AI.
* Maintain end-to-end traceability throughout development.
* Keep documentation aligned with design changes.
* Reduce the manual effort required to prepare for FDA 510(k) submissions.
We're still early in our journey and actively working with industry experts to improve the platform. If you're involved in medical device development, regulatory affairs, quality, or product engineering, I'd genuinely love to hear your feedback.
A few questions I'd love your thoughts on:
* How does your team manage requirements and traceability today?
* What's the most time-consuming part of preparing FDA documentation?
* Where do you think AI can provide the most value in the regulatory process?
I'll be here throughout the day to answer questions and discuss ideas. Thanks for checking out PreQMS—I appreciate your feedback and support!
The traceability matrix view is really well thought out, especially how it links requirements to risks without making you click through five menus. Nice to see a tool that actually understands the FDA workflow instead of just slapping AI on a generic docs editor.
How does it actually keep the AI-generated content aligned with our existing risk files when our team updates a requirement after the docs are already drafted?
Congrats on the launch. One thing that would really help our team is a built-in review workflow where reviewers can leave inline comments on specific sections of the 510(k) draft and track them to resolution, so we stop juggling feedback across email and Word.
About PreQMS on Product Hunt
“AI-powered FDA 510(k) documentation and traceability”
PreQMS was submitted on Product Hunt and earned 0 upvotes and 4 comments, placing #149 on the daily leaderboard. PreQMS helps medical device teams generate FDA 510(k) documentation, manage requirements, and maintain end-to-end traceability using AI.
PreQMS was featured in Productivity (655.7k followers), Artificial Intelligence (473.1k followers) and Medical (3.4k followers) on Product Hunt. Together, these topics include over 253k products, making this a competitive space to launch in.
Who hunted PreQMS?
PreQMS was hunted by Tolga Ciftci, MSCIS. A “hunter” on Product Hunt is the community member who submits a product to the platform — uploading the images, the link, and tagging the makers behind it. Hunters typically write the first comment explaining why a product is worth attention, and their followers are notified the moment they post. Around 79% of featured launches on Product Hunt are self-hunted by their makers, but a well-known hunter still acts as a signal of quality to the rest of the community. See the full all-time top hunters leaderboard to discover who is shaping the Product Hunt ecosystem.
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Tolga Ciftci, MSCIS